Home-based Exercise Program With Smart Rehabilitation System

NCT03282734 | Completed

• 1 other identifier: 2017-07-072
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation therapies have been provided to improve the balance and gait function in stroke patients. However, most rehabilitation therapies are performed in only hospitals, in spite of the difficulty of moving from home to hospitals for stroke patients. Home-based smart rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training program to stroke patients in their home. This study aims to investigate the effects of the home-based exercise program with smart rehabilitation system on balance and gait functions in stroke patients.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Timed Up and Go test

  Assessment of balance and gait function

  Change from baseline Timed Up and Go test at 4 weeks

Secondary Outcomes (6)

• Tinetti Performance Oriented Mobility Assessment

  Change from baseline Timed Up and Go test at 4 weeks

• Berg Balance scale

  Change from baseline Timed Up and Go test at 4 weeks

• Korean-Geriatric Depression Scale- Short Form

  Change from baseline Timed Up and Go test at 4 weeks

• EQ-5D

  Change from baseline Timed Up and Go test at 4 weeks

• Falls Efficacy Scale

  Change from baseline Timed Up and Go test at 4 weeks

Study Arms (2)

The smart rehab group

EXPERIMENTAL

Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks

Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)

The control group

ACTIVE COMPARATOR

Conventional home rehabilitation exercise education for 4 weeks

Other: Conventional home rehabilitation exercise

Interventions

Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) OTHER

Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks

The smart rehab group

Conventional home rehabilitation exercise OTHER

Conventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks

The control group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult stroke patients (more than 18 years old)
• less than 6 months after stroke onset
• discharged to home or the plan to discharge to home less than 3 days
• independent ambulatory function on even level (4 or more than 4 in Functional Ambulatory Category)

You may not qualify if:

• Advanced liver, kidney, cardiac, or pulmonary disease
• A terminal medical diagnosis consistent with survival \< 1 year)
• Pre-existing and active major neurological disease
• Pre-existing and active major psychiatric disease
• Severe language disorders
• Severe cognitive disorders (10 or less than 10 in K-MMSE)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: September 14, 2017
• Study Start: September 18, 2017
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)